ANZCTR search results

The study aims to establish whether taurocholic acid, administered as an enema, can stimulate secretion of the gut peptides GLP-1, PYY, and oxyntomodulin, and suppress subsequent appetite and food intake. This information could be useful in designing treatments for type 2 diabetes and obesity.

We plan to test the hypothesis that, in children with central lines admitted to intensive care, intravenous (through a drip) heparin at a low dose prevents clots developing around the central line, compared to saline, an inactive placebo. Clots will be sought using ultrasound.

Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting Australian children. As well as repeated lung infections, children with CF develop insulin deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis – Insulin Deficiency, Early Action) will determine whether starting insulin treatment before the onset of diabetes (earlier than current practice) will improve the health of children with CF by improving body weight and lung function.

Participants come for one practice visit where they go through the screening questions and provide informed consent. They also practice on all cognitive and mood tasks they will be doing on their subsequent testing sessions. Participants come for 3 testing sessions at least 1 week apart. At each testing session, they first complete baseline 'mood, cognitive, mood' assessments and doppler ultrasound followed by treatment administration. They complete 'mood, cognitive mood' assessment at 40mins and 120mins post dose and doppler at 90mins post dose

This study looks at the effect of a progressive exercise program on shoulder pain and function following nerve injury after neck dissection surgery for cancer. Who is it for? You can join this study if you have undergone neck dissection surgery for head and neck cancer within eight weeks and you have clinical signs of injury to the accessory nerve which includes weakness of shoulder movements. Trial details Participants will be randomly divided into two groups. One group (control) will receive standard care (physiotherapy or a handout of generalised exercises and advice about scar care). The other group will attend the physiotherapy department for a supervised exercise program. This involves progressive strengthening exercises for half an hour, once a week for 12 weeks, with the same exercises performed at home twice a week. Assessments will be carried out at the start of the study and at 3, 6 and 12 months. The study aims to compare levels of pain, disability and shoulder movement in the different groups.

BACKGROUND AND AIMS Middle age (45-54y), when most women experience menopause, is a particularly high risk stage for weight gain in women, and more than half the women in this age group are overweight or obese. Post-menopause is characterised by the absence of oestrogen resulting in abdominal deposition of body fat and subsequent development or exacerbation of metabolic syndrome. An estimated 48% of coronary events in women are attributable to metabolic syndrome, and risk of cardiovascular disease significantly increases after menopause. There is some evidence that intervention can prevent or minimise the body composition changes leading to post-menopausal obesity, making the years immediately prior to menopause a key stage for intervention. Despite the increased health risks associated with menopausal weight gain, no Australian interventions have been developed for this target group. A potential model for intervention exists within the Enhanced Primary Care (EPC) scheme of Medicare (funding of 5 Allied Health visits for those referred by a GP with chronic and complex problems). This model could be extended to the target group of women in the years immediately prior to menopause. The aim of this randomised control trial (the 40-Something Study) is to pilot test the feasibility of applying this model to the prevention of weight gain in non-obese women aged 44-50. Given the RCT will be a pilot of what will hopefully be a wider intervention, it will particularly assess the feasibility of recruiting into the study, ability to retain participants and will test the intervention and information only materials. RESEARCH PLAN The study has been designed to adhere to the CONSORT guidelines. An RCT design is being used to test the ability of a 12 month intensive intervention (four Dietitian appointments and one Exercise Physiologist appointment using motivational interviewing to advise on dietary and physical activity strategies) to prevent weight gain, in comparison to the provision of written information. Women were invited to participate if they were between 44 and 50y, still menstruating, BMI 18.5- 29.9 and able to attend appointments in Newcastle, NSW. Those in the healthy weight range (18.5-24.9kg/m2) at baseline will be given the goal of maintaining weight within 1kg, and provided with weight maintenance advice, (8300kJ/day, and at least 150 mins/week of PA). Women in the overweight range (25-29.9 kg/m2) at baseline will be advised to lose at least 7% of body weight, (by following a 6300kJ/day regime and 250 mins/wk of PA) before being given weight maintenance advice. After baseline data was collected the women were randomly allocated to intervention or control groups. All researchers except the Dietitian conducting the appointments with the intervention group will remain blind to the allocation condition. The primary outcome measures are weight and waist circumference, with secondary measures of biomarkers of metabolic syndrome. Baseline data has been collected on anthropometry, biomarkers of metabolic syndrome, and behaviours influencing weight gain including dietary intake, physical activity and dietary restraint, in addition to health and demographic data. The data will be collected again at 12 months after the intervention commenced. Compliance to the interventions in terms of dietary intake and PA is being measured 3 months after commencing the intervention. The study involves a comparison of a baseline measurement to a single follow-up measure to assess the success of the intervention (baseline to 12 months). Paired t-tests will be used to determine if there is a significant change in weight for each group with sub-analyses for those normal weight and overweight at baseline. Repeated measures analysis of covariance will be used to examine whether the groups (control and intervention) differ significantly on the amount of weight change between baseline and follow up. The project will be monitored by a Management Committee (meeting at least monthly) to oversee project implementation.

Objectives: Primary objective: Improve the vision of patients with diabetic macular oedema (DMO) affecting the centre of the fovea that has persisted despite laser treatment. Secondary objective: Reduce retinal thickness as measured by OCT (optical coherence tomography). Strategic goal: Primary Objective: 1. To determine if combined treatment with ranibizumab and grid laser for recalcitrant diabetic maculopathy is more effective in improving visual acuity than grid laser alone. Secondary Objectives: 1. To design a treatment protocol that requires less visits and intravitreal injections than similar studies currently in progress. This would be more acceptable to patients and clinicians.

Behavioural and psychological symptoms of dementia (BPSD), particularly agitation and aggressive behaviours, are a major cause of distress and are often difficult to manage. Treatment of BPSD is currently focused on suppression of symptoms rather than addressing the triggering factors. Unrelieved pain is very common in older persons in residential aged care facilities and is considered to be a particularly important target within the context of ameliorating BPSD. There have been relatively few studies to examine systematically the relationship between pain and agitation/aggression, as well as other specific types of BPSD, and the evidence for a causal association between these very common conditions is currently lacking. The overall aim of the present study is to undertake a randomised controlled trial of analgesic interventions to specifically monitor changes in pain and consequent changes in the frequency of agitation/aggression and other BPSD in persons with dementia. By completion, we will have important new insights into the strength of causal relationship between pain, aggression/agitation and other types of BPSD (ie. depression), and the first ever evidence on the use of analgesics to relieve pain in older cognitively impaired adults and thereby reduce the frequency of various BPSD. The improved evidence base will help guide future clinical management of agitation/aggression and other BPSD and ultimately contribute to an improved quality of life for persons with dementia and a reduced burden of care and carer stress.

Oxytocin is a natural hormone which plays a critical role in social behavior such as bonding, cooperativeness, trust, emotion recognition and face processing. Autism is a developmental disorder characterized by profound impairments in social behavior, communication and presence of repetitive behaviors. This study aims to assess the efficacy of oxytocin treatment in ameliorating social impairments in young children with autism. In particular, we aim to assess whether oxytocin treatment can improve the capacity for social interaction, face processing and reduce the occurrence of repetitive behaviors.

It is well established that obesity can lead to impaired vascular function. This not only leads to cardiovascular health consequences but may also impact on cognitive function by impairing the delivery of blood flow to the brain. We have recently demonstrated an acute, dose dependent improvement of flow mediated dilatation (FMD) with resveratrol supplementation (ACTRN12609000023257). However, the effects of chronic supplementation are still unknown. FMD is a non-invasive means of assessing blood vessel function. We will now determine whether regular daily consumption of resveratrol for 6 weeks can lead to a sustained improvement in FMD which may result in a decrease in resting BP and enhance cognitive performance. This could be particularly advantageous in potentially improving long term cardiovascular and mental health. The investigation will be undertaken in obese subjects as they are more likely to have impaired FMD without other established risk factors for cardiovascular disease.